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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Succimer
Date Designated: 11/05/1990
Orphan Designation: Prevention of cystine kidney stone formation in patients with homozygous cystinuria who are prone to stone development.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Sanofi Winthrop, Inc.
90 Park Avenue
New York, New York 10016
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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